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CERSI Scholars

CERSI Scholars - Advancing Science to Improve Public Health

About CERSI Scholars

CERSI Scholars is a collaborative effort between the Georgetown CERSI, Georgetown University Medical Center (GUMC), and MedStar Health Research Institute (MHRI). The program engages individuals who are deeply committed to public health and actively pursuing research, education, or training in regulatory science.

CERSI Scholars will raise awareness among their peers and throughout their careers about regulatory science and how its application can improve innovation in medical product development. This program will elevate training and mentorship opportunities for rising leaders in regulatory science.

Benefits

CERSI Scholars are provided with research stipends of up to $5,000 to be applied toward related activities, such as support ongoing research, fees associated with peer-review publication, or travel costs to conferences.

CERSI Scholars have access to structured mentoring from Georgetown and MedStar faculty whose work involves regulatory science as well as FDA staff and scientists.

Duration and Program Activities

This is a one-year program, which allows Scholars to engage with their peers and thought leaders from industry, academia and the FDA to discuss important topics in regulatory science.

Scholars are required to attend all seminars and are expected to give a presentation on their work.

For an overview of the program in its inaugural year, review the Progress Report.

2017-2018 CERSI SCHOLARS

Mr. Belouali is a Bioinformatics Technical Lead and Senior Software Engineer with over 7 years of experience in Healthcare Analytics and Data Integration across heterogeneous platforms. He is involved in the design and development of innovative approaches to integrate disparate data sources, application development as well as maintenance of several clinical research applications within ICBI. Prior to joining ICBI, Mr. Belouali worked as a Systems Analyst for the Imaging Science and Information Systems (ISIS) Center where he developed and implemented several telemedicine and health IT related systems. He earned a Master’s with First Class Honors in Computer Science (Software Quality Engineering track) from Mohammadia Engineering School in Morocco. He is now pursuing a Systems Medicine M.S. at Georgetown University.

Ms. Bond has worked in Clinical Research for close to six years now. In those six years, she has worked mostly in the area of cardiovascular research at MedStar Cardiovascular Research Network (MCRN). More specifically, the research has focused on Transcather Aortic Valve Replacements and other novel structural heart devices. Ms. Bond has a Masters of Public Health in Epidemiology and Biostatistics, and will apply those skills to regulatory science research. Having worked directly with patient enrollment, she is interested in delving further into clinical trial participation within MedStar. The CERSI Scholars program will provide her with the opportunity to look at current clinical trial participation within MedStar. The reach of the MedStar network will provide a unique opportunity for gathering information as well as future steps towards potentially reaching more people. She is interested in learning more about the development of regulatory science and the implications it has had or will have on clinical trial participation and clinical trial development.

Dr. Bradley is currently in training at the MedStar-Georgetown Female Pelvic Medicine and Reconstructive Surgery Fellowship. The program focuses on pelvic floor disorders, such as prolapse and the treatment of urinary and fecal incontinence in women. She completed her residency in Obstetrics and Gynecology at Mountain Area Health Education Center in Asheville, North Carolina before moving to Washington, D.C. She received an award for the study of Clinical and Translational Sciences Research at Georgetown University. She is personally interested in the study and treatment of vulvovaginal disorders, such as vaginal atrophy, lichen sclerosus, and lichen planus. Upon graduating from fellowship, she hopes to pursue a career in academic medicine.

Dr. Dezfuli is an Instructor in the Department of Pharmacology & Physiology at Georgetown University. Her research focuses on nicotinic cholinergic receptors in the control of energy homeostasis, in particular the critical role of nicotinic receptor desensitization (as opposed to activation) in mediating long-term weight loss in animal models of obesity. One goal of Dr. Dezfuli’s research is to apply knowledge gained through her basic science research toward the development of nicotine-based therapeutics for weight loss in human subjects. To this end, Dr. Dezfuli is moving her research clinically to test the efficacy of the transdermal nicotine patch on weight loss in overweight non-smoking subjects in the DC/MD/VA area in a pilot clinical trial. The transdermal nicotine patch is a nicotine delivery system favoring the pharmacokinetics of nicotinic receptor desensitization. The nicotine patch has never been tested before for weight loss in nonsmoking subjects. Rather, previous studies have focused on prevention of post-smoking cessation weight gain. As a CERSI Scholar, Dr. Dezfuli is interested in collaborating with regulatory scientists to gain a better understanding of the regulatory processes governing drug-related clinical research.

Dr. Garman received his medical degree from Tripoli University and worked as a physician for several years before coming to Georgetown University for the PhD program in pharmacology. For his thesis research, he is working with Dr. Anton Wellstein to study the effects of fibroblast growth factor (FGF) signaling on carbohydrate and lipid metabolism with the goal of developing novel treatments for diabetes mellitus and fatty liver. In particular, he is interested in the potential for FGF binding protein BP3 to enhance and extend endogenous FGF control of blood glucose levels. Dr. Garman is also teaching pharmacology and physiology in the Georgetown University School of Nursing and Health Studies, where his dual perspectives as a medical professional and a preclinical researcher help him to prepare his students for effective healthcare provision. The CERSI Scholars program is an invaluable opportunity for him to collaborate with regulatory scientists and apply this experience to his work as a researcher and educator.

Mr. Heitman has been a professional researcher for almost 15 years. After completing his BS in Biology at Hobart College in 2002, he started an IRTA fellowship at the NIH in the NIA’s Laboratory of Genetics. In 2005, he transitioned from pre-clinical bench work to clinical work starting with a position on a contract for the website ClinicalTrials.gov. He then moved directly into clinical research at multiple contract research organizations working on myriad projects for NIH and industry. He is currently a Project Lead at Vanda Pharmaceuticals, where he has worked for the past 5 years. Andrew finished his MS in Pharmacology in 2010 and began the PhD in Pharmacology & Physiology in 2015. His research at Georgetown focuses on a potential disease modifying therapy for Parkinson’s disease.

Mr. Hoffman supports and leads various research and safety projects conducted within the National Center for Human Factors in Healthcare. Primarily concerned with successful research grant execution, he is leading safety initiatives through uncovering current and past practices through medical informatics. Daniel has a specific interest in the combining of industrial engineering practices, big data medical informatics, and safety science through which we can rapidly learn from how we have and are currently delivering care and to designing sustainable interventions to increase, optimize, and efficiently deliver safer care to our patients and community. Mr. Hoffman holds a Bachelor of Science in Industrial and Systems Engineering from The Ohio State University, where he focused on human factors and ergonomics and design.

Dr. Ihemelandu is an Associate Professor of Surgical Oncology at Georgetown University School of Medicine, and an Attending Surgical Oncologist at MedStar Washington Hospital Center. Dr Ihemelandu is a board-certified, fellowship-trained surgical oncologist specializing in: Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy for advanced Gastrointestinal and peritoneal surface malignancies including: gastric cancer, colorectal cancer, appendix cancer, mesothelioma, pancreatic cancer, sarcoma. Dr. Ihemelandu completed his surgical oncology fellowship at Wake Forest University School of Medicine. He is a fellow of the American College of Surgeons and has published numerous articles in peer-reviewed journals. Dr. Ihemelandu’s research interests include analyzing the use of near-infrared fluorescent technology to look for microscopic cancer during surgery to aid in the complete removal of a disease. He is also analyzing the molecular profile of unique tumors in the abdomen to understand how treatment can be personalized for each patient.

Dr. Kawakita is a Maternal-Fetal Medicine Fellow at MedStar Georgetown University Hospital (MGUH) and MedStar Washington Hospital Center (MWHC). In 2009, he received his MD from Kanazawa University School of Medicine in Japan. In 2017, he completed an Obstetrics and Gynecology residency at MGUH and MWHC. He envisions becoming an academician who advances the field of obstetrics and maternal-fetal medicine through clinical research and regulatory science. His special research interests include obesity and the impact on pregnancy. He is currently working on a project with Dr. Rachael Overcash and Dr. Sara Iqbal examining the use of Negative Pressure Wound Therapy (NPWT) systems in morbidly obese women after cesarean delivery. NPWT is an innovative device whose application after cesarean delivery has not been fully investigated. Understanding the effectiveness of NPWT systems in obese women after cesarean delivery will allow clinicians to improve wound healing in this population. The CERSI Scholars programs will provide him with the opportunity to engage with leaders from industry, academia, and the Food and Drug Administration to further his research and career goals.

Ms. Wenzel’s interest in basic science research developed when she was an undergraduate at University of California, Los Angeles (UCLA) majoring in Biochemistry. During this time, she had the opportunity to work as an undergraduate research assistant in several labs and found that her favorite experience was in the Department of Molecular and Medical Pharmacology at UCLA. She then chose Georgetown University and the Department of Pharmacology & Physiology to continue her studies and move forward in my goal of obtaining a PhD. Georgetown’s proximity to many institutions, including the NIH and the FDA, was essential to her decision making. The location of the university allows for collaborations both at the levels of basic science and translational research, as well as the implementation of basic research in the clinical setting. At Georgetown, her thesis research combines her expertise in pharmacology and biochemistry to work on elucidating potential new therapeutic targets and effective therapies for neurodegenerative disorders. She believes that knowledge, collaboration, communication, and understanding throughout all levels of the drug development process is essential to ensure high productivity, safety, and success.

2016-2017 CERSI SCHOLARS

Dr. Cook is the Chief Pharmacist for Provider Resources, Inc. (PRI), a consulting firm based in Erie, PA. In this role, he provides drug information support, clinical expertise, policy guidance and oversight to two of PRI’s national contracts within the Centers for Medicare and Medicaid Services (CMS). Dr. Cook received a Doctor of Pharmacy Degree (PharmD) from Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy, completed an American Society of Health-System Pharmacists accredited Post-Graduate Year One (PGY1) Pharmacy Residency at Hillcrest Hospital – A Cleveland Clinic Hospital, and completed his MS in Clinical and Translational Research, Regulatory Science concentration, from Georgetown University in 2016. Dr. Cook has a demonstrated yet nascent interest in regulatory science. His research interests include using real-world data to inform the FDA about the effectiveness of public-facing communications, including drug labels, medication guides, and drug safety alerts to prescribers; he has presented related research at the FDA and at national conferences.

Ms. Djemil’s thesis research focuses on the role of nicotinic cholinergic receptors in modulating neural network dynamics and how nicotine, a widely used addictive drug, shifts the default state of the network. Although nicotine has been implicated in promoting cancer, many studies have shown that nicotine is also a neuroprotective cognitive enhancer. This dual effect of risk and benefit is not unique to nicotine, and is one of the main reasons that regulatory science is an essential discipline within the biomedical field. Ms. Djemil believes that there is an inherent ethical obligation on every participant in the drug discovery process, whether at the basic or translational level, to ensure that these risks and benefits are clearly communicated. As a pharmacologist, Ms. Djemil’s goal is to advance innovation in drug discovery and medical products. The CERSI Scholar program will facilitate her arrival at this goal as she gains access to the necessary training and mentorship by leaders in regulatory science.

Dr. Hettinger is an Assistant Professor of Emergency Medicine at Georgetown University of School of Medicine and the Medical Director of the National Center for Human Factors in Healthcare. He is board certified in Emergency Medicine and Clinical Informatics and has a Master of Science in Clinical Investigation. In these roles, Dr. Hettinger has the opportunity to translate the languages of medicine, informatics, and human factors with the goal of improving patient safety and healthcare processes. His primary interests include health information technology, adverse event analysis, and data visualization as they pertain to reducing hazards in the healthcare environment. He has received funding from the NIH, ONC, AHRQ, VA, and several foundations to pursue these avenues of applied research while practicing clinically at MedStar Union Memorial Hospital. As a CERSI Scholar, he is particularly interested in how regulatory science can be used to study the role of health IT systems in the safe use of medications, specifically preventing Look-Alike/Sound-Alike medication errors.

Ms. Huizenga’s thesis research, under the direction of Dr. Patrick Forcelli, focuses on elucidating specific molecular targets that contribute to the development and persistence of epilepsy despite anti-epileptic drug (AED) treatments. The current first and second line drug treatments for epilepsy are wrought with both adverse developmental and cognitive consequences. Despite the emergence of newer AEDs, some of these adverse effects still persist. To address this treatment gap, Megan is evaluating the therapeutic potential of novel receptor targets in a neonate animal model of epilepsy in addition to using a zebrafish model for high throughput screening of the effect of numerous AEDs on neuronal apoptosis. Additionally, in an adult animal model of epilepsy, Ms. Huizenga is determining the role of the upregulation of localized brain-derived neurotrophic factor in neuronal dendrites as a mechanistic contributor to seizure development. This work will elucidate a potential drug target that will aim to prevent the progression of seizure activity into epilepsy. Using this two-pronged approach, she will determine novel therapeutic targets that minimize adverse effects, for the treatment of epilepsy. In these drug discovery efforts, Ms. Huizenga is looking at both the effect of current AED treatments in neonatal development and identifying molecular drivers of seizure development in adult animal models.

Ms. Javidnia is working toward her PhD in pharmacology, under the mentorship of Dr. Charbel Moussa, who has successfully taken the FDA-approved cancer drug nilotinib from cells to animal models to his upcoming Phase II clinical trial in Parkinson's disease. In addition to working with Dr. Moussa, Ms. Javidnia will be working on preclinical research on a new compound to see if it will also be a potential therapeutic for neurodegenerative diseases, a unique research opportunity. Ms. Javidnia works closely with Dr. Moussa to learn about the vast amounts of regulatory requirements associated with taking a drug from the bench to the bedside. She is very passionate about this translational work and wishes to continue in the field after graduation.

Dr. Jensen is an Assistant Professor at Georgetown University in the Department of Oncology and a member of the Cancer Prevention and Control Program at the Lombardi Comprehensive Cancer Center. Dr. Jensen is an expert in the development and validation of patient-reported outcomes (PROs) measures in oncology, with a focus on new NIH-sponsored measurement systems (PROMIS and PRO-CTCAE). Her research interests include: measuring cancer treatment-related symptoms, function, and quality of life and integrating routine electronic symptom screening in clinical care settings. She is interested in collaborating with regulatory scientists to better understand how PROs are evaluated and certified as clinical outcome assessments.

Mindi Messmer, MS Student, Regulatory Science Program, GUMC

Ms. Messmer is interested in the areas of neurological disorders and developing better ways of incorporating drug development tools. For example, interests include developing objective ways to incorporate the voice of the patient in assessing drug efficacy. Her interests also include regulatory innovation for developing clinical trials. She began her studies in the MS in Clinical and Translational Science program, regulatory science concentration, in 2014 as a part-time student. Ms. Messmer has worked for more than 25 years as an environmental analyst and consultant, and developed an interest in regulatory science as an encore career. The concepts and analytic approaches that she has relied upon in her environmental work are closely related to the approaches needed for drug development – to balance risk and benefit favorably, to ensure people are protected from harm as much as possible. The CERSI Scholars program will provide Ms. Messmer with the opportunity to further engage with the GU CERSI and regulatory scientists from all of its key stakeholders, including FDA.

Ms. Purks is the Program Manager of Clinical Trials at the Huntington Disease Care, Education, and Research Center (HDCERC). At the center, Ms. Purks manages and conducts two HD clinical trials (SIGNAL-HD and PRIDE-HD), one observational HD trial (ENROLL-HD), and two Tardive Dyskinesia (TD) Clinical Trials (AIM-TD and RIM-TD). Her primary research interest is in Patient Reported Outcomes and the challenge of effectively capturing and analyzing patient reported cognitive symptoms in a neurodegenerative disease population. Working in Clinical Trials and Patient Reported Outcomes research in Huntington Disease for over two years, Ms. Purks has been inspired by what regulatory science has to offer all stakeholders in the research community and impressed with how much current investigation and present research gaps fall under regulatory science. As a junior investigator, Ms. Purks will utilize the CERSI Scholar award to present current research at national and international society meetings, benefit from rich dialogue with expert colleagues in the field, publish results, and continue to foster growth and exploration of regulatory science research. Ms. Purks is currently applying to medical school to matriculate in August 2017.

Ms. Savage focuses on health IT policy and is currently working on a project with Dr. Raj Ratwani and Dr. Terry Fairbanks comparing the regulatory and enforcement mechanisms used by federal agencies, Federal Aviation Administration, Food and Drug Administration and Office of the National Coordinator for Health Information Technology (ONC), to identify regulatory mechanisms used in other industries that could be leveraged to optimize the usability of electronic health records. She is also working on an ONC contract that aims to identify gaps and steps forward that federal agencies and the larger community can take to optimize EHR implementation and use. Ms. Savage is currently working toward her Master of Healthcare Administration at the University of North Carolina (as a distance learner). Her studies and current projects have piqued her interest in how regulatory science can drive improvements in patient and provider safety and public health.

Ms. Torguson has worked in a research capacity with MedStar Health for almost 15 years, assisting with and conducting clinical research and associated activities. At MedStar she has developed an academic clinical research organization that facilitates the investigator-sponsored research both as a single center (MWHC) and multicenter clinical trials. These trials include phase 3b IND, IDE and observational studies. She obtained her MPH in Biostatistics from Columbia University in 2007 and returned to MedStar. She has co-authored over 250 peer-reviewed manuscripts, with several focusing specifically on regulatory sciences. Currently she supervises a team of project leads who manage MedStar Cardiovascular Research Network’s clinical trials; these works include protocol design, protocol writing, FDA submission (when necessary), regulatory oversight, site oversight, data management, statistical analysis and final manuscript/ report generation. Additionally, she manages the internal epidemiological research being conducted for cardiology within MedStar Heart and Vascular Institute (MHVI). Rebecca applies regulatory practices in her daily activity, and she is interested in the scientific approaches and tools that underpin these regulations and guidances. Being appointed as a CERSI Scholar will provide Ms. Torguson with opportunities to expand her horizons in this regard.

FOR MORE INFORMATION

If you have questions about the CERSI Scholars program, contact Erin Wilhelm, MPH, Executive Director, Program for Regulatory Science & Medicine, Georgetown University (eew6@georgetown.edu).